Atopic DermatitisPhase 4MODA-ADNCT07848074
Abrocitinib Dose Tapering in Patients With Atopic Dermatitis
A Phase 4 study testing Abrocitinib in people with Atopic Dermatitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
This prospective, multicenter study aims to evaluate whether patients with moderate-to-severe atopic dermatitis who achieve optimal disease control during treatment with abrocitinib 200 mg once daily can maintain disease control following dose reduction to 100 mg once daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Abrocitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years. Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria for at least 6 months.
- Moderate-to-severe atopic dermatitis meeting applicable criteria for systemic treatment.
- Receiving abrocitinib 200 mg once daily for at least 3 months. Achievement of Minimal Disease Activity at two consecutive visits at least one month apart; the second visit will constitute the baseline visit for study enrollment and dose tapering.
- Ability to provide written informed consent. Ability and willingness to attend scheduled study visits. -
Who cannot join
- Presence of another skin disease that may interfere with the diagnosis or clinical assessment of atopic dermatitis.
- Concomitant treatment with systemic immunosuppressive or immunomodulatory therapy for another inflammatory or autoimmune condition.
- Inability to provide informed consent. Inability or unwillingness to attend scheduled follow-up visits.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Maintenance of Optimal Disease Control During Abrocitinib Dose Tapering in Patients With Atopic Dermatitis
This prospective, multicenter study aims to evaluate whether patients with moderate-to-severe atopic dermatitis who achieve optimal disease control during treatment with abrocitinib 200 mg once daily can maintain disease control following dose reduction to 100 mg once daily.
Adult patients who have achieved Minimal Disease Activity (MDA) at two consecutive visits at least one month apart will undergo abrocitinib dose tapering from 200 mg/day to 100 mg/day. Patients will be evaluated at Weeks 4, 16, and 32 after dose reduction. The primary objective is to determine the proportion of patients maintaining MDA following dose tapering and to explore clinical factors associated with successful maintenance of disease control.
Additional outcomes include changes in disease severity, itch, sleep disturbance, quality of life, treatment adherence, involvement of difficult-to-treat anatomical areas, use of topical therapies, and treatment safety and tolerability.
Read the detailed description
Atopic dermatitis (AD) is a chronic inflammatory skin disease that may require long-term systemic treatment. Abrocitinib is an oral selective Janus kinase 1 inhibitor approved for the treatment of moderate-to-severe AD. While the 200-mg daily dose provides rapid and effective disease control, selected patients achieving sustained optimal response may potentially maintain disease control after dose reduction to 100 mg/day.
This prospective, multicenter study will enroll adult patients with moderate-to-severe AD receiving abrocitinib 200 mg once daily who have achieved Minimal Disease Activity (MDA) at two consecutive visits at least one month apart. The second assessment confirming MDA will constitute the study baseline, at which abrocitinib will be reduced from 200 mg/day to 100 mg/day.
Clinical assessments will be performed at Weeks 4, 16, and 32 after dose tapering. MDA will be defined by the concurrent achievement of at least one predefined optimal clinician-reported outcome and at least one predefined optimal patient-reported outcome. Clinician-reported measures will include Eczema Area and Severity Index (EASI), Hand Eczema Severity Index (HECSI), and assessment of head and neck involvement. Patient-reported outcomes will include itch Numerical Rating Scale (NRS), sleep NRS, Dermatology Life Quality Index (DLQI), and Atopic Dermatitis Control Tool (ADCT).
The study will evaluate the proportion of patients maintaining MDA after dose tapering, identify potential predictors of successful maintenance of disease control, and assess changes in efficacy, treatment adherence, topical therapy use, and safety. In patients who experience clinically relevant loss of disease control, abrocitinib may be re-escalated to 200 mg/day according to physician judgment.
- Conditions
- Atopic Dermatitis
- Being tested
- Abrocitinib
- Keywords
- atopic dermatitis, abrocitinib
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbrocitinibDrug
Participants who have achieved sustained Minimal Disease Activity while receiving abrocitinib 200 mg once daily will undergo dose reduction to abrocitinib 100 mg once daily at study baseline. Treatment with abrocitinib 100 mg once daily will be continued during follow-up. In case of clinically relevant loss of disease control, the dose may be re-escalated to 200 mg once daily according to physician judgment.
| Study group | Role | What they receive |
|---|---|---|
| abrocitinib dose tapering | Experimental | Participants with atopic dermatitis who have achieved sustained Minimal Disease Activity while receiving abrocitinib 200 mg once daily will undergo dose reduction to abrocitinib 100 mg once daily at study baseline. Participants will be followed at Weeks 4, 16, and 32 after dose tapering. In case of clinically relevant loss of disease control, the abrocitinib dose may be re-escalated to 200 mg once daily according to physician judgment. Receives: Drug: Abrocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Maintaining Minimal Disease Activity at Week 16
Proportion of participants who maintain Minimal Disease Activity (MDA) 16 weeks after abrocitinib dose reduction from 200 mg/day to 100 mg/day without dose re-escalation. MDA is defined as the concurrent achievement of at least one predefined clinician-reported optimal target (EASI ≤3 or EASI-90) and at least one predefined patient-reported optimal target (peak pruritus NRS ≤1, sleep NRS ≤1, or DLQI 0-1).
Measured: 16 weeks after dose tapering
Proportion of Participants Maintaining Minimal Disease Activity at Week 32
Proportion of participants who maintain Minimal Disease Activity (MDA) 32 weeks after abrocitinib dose reduction from 200 mg/day to 100 mg/day without dose re-escalation. MDA is defined as the concurrent achievement of at least one predefined clinician-reported optimal target (EASI ≤3 or EASI-90) and at least one predefined patient-reported optimal target (peak pruritus NRS ≤1, sleep NRS ≤1, or DLQI 0-1).
Measured: 32weeks after dose tapering
Secondary outcomes (2)
Change in Eczema Area and Severity Index
Change in EASI score following abrocitinib dose tapering. EASI ranges from 0 to 72, with higher scores indicating greater disease severity.
Measured: Baseline and Weeks 4, 16, and 32
Maintenance of EASI-50, EASI-75, and EASI-90 Responses
Proportion of participants maintaining at least 50%, 75%, or 90% improvement in EASI relative to the pretreatment baseline assessment.
Measured: week 4,16,32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants who have achieved sustained Minimal Disease Activity during treatment with abrocitinib 200 mg/day will undergo dose reduction to abrocitinib 100 mg/day and will be followed prospectively for 32 weeks.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ketty Peris, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848074
- Sponsor's protocol ID
- 27976
- Acronym
- MODA-AD
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance of Optimal Disease Control During Abrocitinib Dose Tapering in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07848074
- Acronym / sponsor ID
- MODA-AD / 27976
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, abrocitinib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, multicenter study aims to evaluate whether patients with moderate-to-severe atopic dermatitis who achieve optimal disease control during treatment with abrocitinib 200 mg once daily can maintain disease control following dose reduction to 100 mg once daily.
Adult patients who have achieved Minimal Disease Activity (MDA) at two consecutive visits at least one month apart will undergo abrocitinib dose tapering from 200 mg/day to 100 mg/day. Patients will be evaluated at Weeks 4, 16, and 32 after dose reduction. The primary objective is to determine the proportion of patients maintaining MDA following dose tapering and to explore clinical factors associated with successful maintenance of disease control.
Additional outcomes include changes in disease severity, itch, sleep disturbance, quality of life, treatment adherence, involvement of difficult-to-treat anatomical areas, use of topical therapies, and treatment safety and tolerability.
Detailed description
Atopic dermatitis (AD) is a chronic inflammatory skin disease that may require long-term systemic treatment. Abrocitinib is an oral selective Janus kinase 1 inhibitor approved for the treatment of moderate-to-severe AD. While the 200-mg daily dose provides rapid and effective disease control, selected patients achieving sustained optimal response may potentially maintain disease control after dose reduction to 100 mg/day.
This prospective, multicenter study will enroll adult patients with moderate-to-severe AD receiving abrocitinib 200 mg once daily who have achieved Minimal Disease Activity (MDA) at two consecutive visits at least one month apart. The second assessment confirming MDA will constitute the study baseline, at which abrocitinib will be reduced from 200 mg/day to 100 mg/day.
Clinical assessments will be performed at Weeks 4, 16, and 32 after dose tapering. MDA will be defined by the concurrent achievement of at least one predefined optimal clinician-reported outcome and at least one predefined optimal patient-reported outcome. Clinician-reported measures will include Eczema Area and Severity Index (EASI), Hand Eczema Severity Index (HECSI), and assessment of head and neck involvement. Patient-reported outcomes will include itch Numerical Rating Scale (NRS), sleep NRS, Dermatology Life Quality Index (DLQI), and Atopic Dermatitis Control Tool (ADCT).
The study will evaluate the proportion of patients maintaining MDA after dose tapering, identify potential predictors of successful maintenance of disease control, and assess changes in efficacy, treatment adherence, topical therapy use, and safety. In patients who experience clinically relevant loss of disease control, abrocitinib may be re-escalated to 200 mg/day according to physician judgment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants who have achieved sustained Minimal Disease Activity during treatment with abrocitinib 200 mg/day will undergo dose reduction to abrocitinib 100 mg/day and will be followed prospectively for 32 weeks.
| Arm | Type | Receives |
|---|---|---|
| abrocitinib dose tapering | Experimental | Drug: AbrocitinibParticipants with atopic dermatitis who have achieved sustained Minimal Disease Activity while receiving abrocitinib 200 mg once daily will undergo dose reduction to abrocitinib 100 mg once daily at study baseline. Participants will be followed at Weeks 4, 16, and 32 after dose tapering. In case of clinically relevant loss of disease control, the abrocitinib dose may be re-escalated to 200 mg once daily according to physician judgment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years. Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria for at least 6 months.
- Moderate-to-severe atopic dermatitis meeting applicable criteria for systemic treatment.
- Receiving abrocitinib 200 mg once daily for at least 3 months. Achievement of Minimal Disease Activity at two consecutive visits at least one month apart; the second visit will constitute the baseline visit for study enrollment and dose tapering.
- Ability to provide written informed consent. Ability and willingness to attend scheduled study visits. -
Key exclusion criteria (4 listed)
- Presence of another skin disease that may interfere with the diagnosis or clinical assessment of atopic dermatitis.
- Concomitant treatment with systemic immunosuppressive or immunomodulatory therapy for another inflammatory or autoimmune condition.
- Inability to provide informed consent. Inability or unwillingness to attend scheduled follow-up visits.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbrocitinibParticipants who have achieved sustained Minimal Disease Activity while receiving abrocitinib 200 mg once daily will undergo dose reduction to abrocitinib 100 mg once daily at study baseline. Treatment with abrocitinib 100 mg once daily will be continued during follow-up. In case of clinically relevant loss of disease control, the dose may be re-escalated to 200 mg once daily according to physician judgment. | Drug | abrocitinib dose tapering |
Primary outcome
Proportion of Participants Maintaining Minimal Disease Activity at Week 16
Time frame: 16 weeks after dose tapering
Proportion of participants who maintain Minimal Disease Activity (MDA) 16 weeks after abrocitinib dose reduction from 200 mg/day to 100 mg/day without dose re-escalation. MDA is defined as the concurrent achievement of at least one predefined clinician-reported optimal target (EASI ≤3 or EASI-90) and at least one predefined patient-reported optimal target (peak pruritus NRS ≤1, sleep NRS ≤1, or DLQI 0-1).
Proportion of Participants Maintaining Minimal Disease Activity at Week 32
Time frame: 32weeks after dose tapering
Proportion of participants who maintain Minimal Disease Activity (MDA) 32 weeks after abrocitinib dose reduction from 200 mg/day to 100 mg/day without dose re-escalation. MDA is defined as the concurrent achievement of at least one predefined clinician-reported optimal target (EASI ≤3 or EASI-90) and at least one predefined patient-reported optimal target (peak pruritus NRS ≤1, sleep NRS ≤1, or DLQI 0-1).
2 secondary outcomes
Change in Eczema Area and Severity Index
Time frame: Baseline and Weeks 4, 16, and 32
Maintenance of EASI-50, EASI-75, and EASI-90 Responses
Time frame: week 4,16,32
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ketty Peris principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abrocitinib in people with Atopic Dermatitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ketty Peris, Prof (+390630157258, ketty.peris@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Maintaining Minimal Disease Activity at Week 16 (time frame: 16 weeks after dose tapering). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.